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Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial

RecruitingNAAges 18 Years - anyAllBrazilian Institute of Robotic Surgery
NCT07190638 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Renal function preservation is a growing concern in the surgical management of kidney tumors, particularly with the rise in chronic kidney disease worldwide. Recent surgical innovations have focused on modifying renorrhaphy techniques to minimize renal damage. Emerging evidence suggests that omitting cortical suturing may reduce operative time, blood loss, and renal parenchymal loss without increasing major complications. This randomized controlled trial aims to compare outcomes between medullary-only and combined cortical-medullary suture techniques during robot-assisted partial nephrectomy, with the goal of identifying the approach that best balances functional preservation and surgical safety.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of renal mass confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) * Indication for partial nephrectomy * Written informed consent * Expected survival of at least 6 months * Eastern Cooperative Oncology Group (ECOG) score performance status ≤ 1 * Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential * Recovery from any prior therapy-related toxicity to grade 1 or better * If a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC) Exclusion Criteria: * Solitary kidney * Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months * Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) \< 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4) * Bleeding diathesis * Inability to maintain anticoagulation for surgery * Participation in another experimental trial simultaneously or within 30 days prior to enrollment * Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety, limit study completion, or impair study objectives in the opinion of the Principal Investigator
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What it tests

  • Medullary-only suturing (single-layer)
  • Suture
  • Medullary and cortical suturing (two-layer)
  • Suture
  • Hemostatic Agent
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Where

2 sites
Hospital MaterDei Salvador
Salvador, Brazil
Brazilian Institute of Robotic Surgery
Salvador, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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